| CTRI Number |
CTRI/2018/10/016013 [Registered on: 15/10/2018] Trial Registered Prospectively |
| Last Modified On: |
22/09/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Homeopathic treatment of painful menses |
|
Scientific Title of Study
|
Efficacy of Individualized Homeopathic Medicines in Primary Dysmenorrhoea:
A Double-blind, Randomized, Placebo-controlled Clinical Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1221-8387 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rai Khushboo Ravindra |
| Designation |
Postgraduate Trainee |
| Affiliation |
Mahesh Bhattacharyya Homoeopathic Medical College and Hospital |
| Address |
Drainage Canal Road, Doomurjola, Howrah
Haora
WEST BENGAL
711104
India |
| Phone |
7985399380 |
| Fax |
|
| Email |
ksb26592@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shubhamoy Ghosh |
| Designation |
Professor and Head, Department of Pathology and Microbiology |
| Affiliation |
Mahesh Bhattacharyya Homoeopathic Medical College and Hospital |
| Address |
Drainage Canal Road, Doomurjola, Howrah 711104
Haora
WEST BENGAL
711104
India |
| Phone |
8240773920 |
| Fax |
|
| Email |
shubhamoy67@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shubhamoy Ghosh |
| Designation |
Professor and Head, Department of Pathology and Microbiology |
| Affiliation |
Mahesh Bhattacharyya Homoeopathic Medical College and Hospital |
| Address |
Drainage Canal Road, Doomurjola, Howrah 711104
WEST BENGAL
711104
India |
| Phone |
8240773920 |
| Fax |
|
| Email |
shubhamoy67@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mahesh Bhattacharyya Homoeopathic Medical College and Hospital; Drainage Canal Road, Doomurjola, Howrah - 711104; West Bengal; India |
|
|
Primary Sponsor
|
| Name |
Mahesh Bhattacharyya Homoeopathic Medical College and Hospital |
| Address |
Drainage Canal Road, Doomurjola, Howrah 711104, West Bengal, India |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Rai Khushboo Ravindra |
OPD room no 5, Dept of Obstetrics and Gynaecology, M B H Medical College & Hospital |
Drainage Canal Road, Doomurjola, Howrah 711104
Haora
WEST BENGAL |
7985399380
ksb26592@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N944||Primary dysmenorrhea, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualized homeopathic medicines in centesimal potencies |
Intervention is planned as administering indicated homeopathic remedies in centesimal potencies. Each dose consists of 4-6 cane sugar globules moistened with the indicated medicine (preserved in 90% v/v ethanol), to be taken orally on clean tongue with empty stomach; dosage and repetition depending upon the individual requirement of the cases. All medicines will be procured from a Good Manufacturing Practice (GMP)-certified firm. Along with medicines, the intervention arm will receive psychological counselling regarding proper diet, regimen, hygiene and reassurance. |
| Comparator Agent |
Placebo |
This group will receive indistinguishable placebo. Each dose consists of 4-6 cane sugar globules moistened with 90% v/v ethanol, to be taken orally on clean tongue with empty stomach; dosage and repetition depending upon the individual requirement of the cases. Along with placebo, this arm will receive psychological counselling regarding proper diet, regimen, hygiene and reassurance. |
|
|
Inclusion Criteria
|
| Age From |
13.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
a) Female cases suffering from primary dysmenorrhoea, pain score of 4 to 9 on Numeric Rating Scale in the last three cycles
b) Age between 13 and 45 yrs
c) Capability and willingness to give informed consent and to comply with the study procedure |
|
| ExclusionCriteria |
| Details |
a) Cases suffering from severe dysmenorrhea, are too sick for consultation
b) Cases suffering with secondary dysmenorrhea
c) Patients using oral contraceptive pills, hormone replacement therapy or corticosteroids or having a history of their use in previous 3 months
d) Unevaluated gynaecological abnormalities; e.g. unexplained vaginal bleeding, cervical dysplasia, pelvic inflammatory diseases (PID) within one month, patients with suspicious adenomyosis, gross developmental defect or congenital abnormalities of the uterus etc. or patients having history of breast or reproductive organ cancer or patients underwent hysterectomy and/or bilateral oophorectomy or change in hormone status (introduction of an oestrogen and/or progestogen, amenorrhoea, pregnancy etc.)
e) Diagnosed cases of uncontrolled systemic diseases, unstable mental or psychiatric illness or other uncontrolled or life-threatening illness affecting quality of life or any organ failure
f) Undergoing homoeopathic treatment for chronic disease within last 6 months
g) Self-reported immune-compromised state
h) Patient with psychiatric disorders
i) Patients unable to read patient information sheet
j) Patients unwilling to take part or not giving consent to join the study
k) Substance abuse and/or dependence
l) Cases requiring immediate surgical intervention |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 0-10 Numeric Rating Scale (NRS) measuring intensity of pain of dysmenorrhea |
At baseline, every month up to 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Verbal Multidimensional scoring system assessing the severity of dysmenorrhea symptoms and its associated symptoms |
At baseline, every month up to 3 months |
|
|
Target Sample Size
|
Total Sample Size="128"
Sample Size from India="128"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
01/11/2018 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None yet; to be published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Primary
dysmenorrhoea refers to one that is not associated with any identifiable pelvic
pathology. The pathogenesis of pain is attributed to a biochemical derangement.
It affects more than 50% post pubescent women in the age group of 18–25 years
with ovulatory cycles. Homeopathy treatment for the said condition is claimed to be beneficial,
still systematic research evidences remain compromised. This study has been undertaken to examine the efficacy of individualised homeopathic medicines against placebo in treatment of primary dysmenorrhea. In this prospective, double blind, randomised, placebo controlled,
parallel arm trial at Mahesh Bhattacharyya Homoeopathic Medical College and
Hospital, 128 patients suffering from primary dysmenorrhea will be randomised in 1:1
ratio into either individualised homeopathic treatment or identical
placebo. A 0-10 Numeric Rating Scale (NRS) measuring intensity of pain of dysmenorrhea and Verbal Multidimensional scoring system (VMSS) assessing the severity of dysmenorrhea symptoms and its
associated symptoms will be used as the primary and secondary outcome measures
respectively, measured at baseline, and every month up to 3 months. At the end
of 3 months, comparative analysis will be carried out to detect group
differences, if any. Results will be published in scientific journals. |